Study of ODX (OsteoDex) in Multiple Myeloma

The current phase I/IIa trial is a multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX. Each dose cohort will consist of 4 subjects. Each subject will receive up to 7 doses of ODX, given at 2-week intervals, until unacceptable toxicity or disease progression. A follow-up visit will be conducted 2 weeks after the last dose. Primary objectives: • To determine the safety and tolerability of ODX in subjects with relapsed/refractory multiple myeloma. Secondary objectives: * To evaluate the preliminary efficacy of O

Trial Details

NCT ID
NCT06616389
Phase
PHASE1 / PHASE2
Sponsor
DexTech Medical AB
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • ODX (Osteodex)
Locations (sample)
  • Stockholm, Sweden|59.32938,18.06871
  • Uddevalla, Sweden|58.34784,11.9424

Key Eligibility Criteria

  • 1\. Subject (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • 2\. Documented diagnosis av multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria.
  • 3\. Measurable disease defined as either:
  • Serum monoclonal paraprotein (M-protein) level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or

For full eligibility, visit ClinicalTrials.gov.

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